BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 1954809 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00529
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 2, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC DUE TO A VIBRATORY ALERT. UPON INTERROGATION, THE HIGH VOLTAGE LEAD IMPEDACE MEASUREMENT FOR SVC TO CAN NOTED NO MEASUREMENT. A LOOSE SETSCREW WAS SUSPECTED. THE SVC COIL WAS TURNED OFF AND DFT WITH RV TO ICD CAN WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 7000/65 (B)(4)